Effects of Bright-light Exposure Combined With Specific Exercise Training (BEST) Program in Patients With Cancer
NCT ID: NCT05875870
Last Updated: 2024-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-07-24
2028-05-15
Brief Summary
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Detailed Description
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Two groups, parallel, randomly assigned clinical trials, long-term follow-up, repeated measurement (pre-test, 6th week, 12th week, 6th month, 12th month, five times in total), and a design of single center recruitment. The experimental group receiving an intervention comprised six weeks of light exposure combined with exercise training. The active control group receiving six weeks of stretching exercise. With a double-blind study design of participant blind and outcomes assessor blind, subjects were recruited from the thoracic surgery clinic and thoracic surgery ward of a medical center in northern Taiwan.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Experimental group
The rehabilitation program is composed of two parts: six-week bright-light exposure program and an exercise program.
Daylight exposure combine walking
1. Out-door of bright-light exposure in the morning (36 min/day, 7 times/week) for six weeks.
2. Tailored to the individual patient with moderate intensity of walking (3 sessions/week) for six weeks. Duration of each session depends on one-on-one exercise consultation via communication software (LINE App). The duration of walking in week 1 is 15 minutes, then increasing 5 minutes each week if the patient has tolerance. If the patient cannot tolerate the duration, the coach will instruct to keep the same duration for the following week. Basically, the goal of duration in week six is 40 minutes.
3. Weekly exercise consultation via communication software (LINE App).
4. Teaching strategy includes one-on one instruction (hard-copy of teaching manual), video, and webpage.
Active control group
The active control group receives six weeks of a stretching exercise.
Stretching exercise
The stretching exercise includes two movements for the upper body and two movements for the lower body, 10 minutes each time, three times a week, for 6 weeks.
The researcher will explain to the participants about how to perform the stretching exercise, according to an instruction manual (hardcopy) for the exercise regimen.
A video is shown to the participants (the content same as hardcopy of education manual).
Interventions
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Daylight exposure combine walking
1. Out-door of bright-light exposure in the morning (36 min/day, 7 times/week) for six weeks.
2. Tailored to the individual patient with moderate intensity of walking (3 sessions/week) for six weeks. Duration of each session depends on one-on-one exercise consultation via communication software (LINE App). The duration of walking in week 1 is 15 minutes, then increasing 5 minutes each week if the patient has tolerance. If the patient cannot tolerate the duration, the coach will instruct to keep the same duration for the following week. Basically, the goal of duration in week six is 40 minutes.
3. Weekly exercise consultation via communication software (LINE App).
4. Teaching strategy includes one-on one instruction (hard-copy of teaching manual), video, and webpage.
Stretching exercise
The stretching exercise includes two movements for the upper body and two movements for the lower body, 10 minutes each time, three times a week, for 6 weeks.
The researcher will explain to the participants about how to perform the stretching exercise, according to an instruction manual (hardcopy) for the exercise regimen.
A video is shown to the participants (the content same as hardcopy of education manual).
Eligibility Criteria
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Inclusion Criteria
2. At least 20 years of age.
3. Able to communicate in Mandarin Chinese or Taiwanese.
4. Literate and free from cognitive disabilities.
5. The attending physician agrees to participate in the study.
6. Those who can connect to the Internet with mobile devices such as computers, mobile phones, and tablets, or those whose family members can assist in the operation.
7. Those with Karnofsky Performance Scale (KPS) greater than or equal to 70 points.
8. Those who are hospitalized for lung cancer or esophageal cancer lesion resection.
Exclusion Criteria
2. Orthopedic diseases of the lower extremities that limit one's walking ability.
20 Years
ALL
No
Sponsors
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National Taipei University of Nursing and Health Sciences
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Responsible Party
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Principal Investigators
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Hui-Mei Chen, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taipei University of Nursing and Health Sciences
Locations
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Taipei Veterans General Hospital
Taipei City, Taipei, Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.
Chen HM, Cheung DST, Lin YY, Wu YC, Liu CY, Lin KC, Lin YJ, Lin CC. Relationships of exercise timing with sleep, fatigue and rest-activity rhythms of lung cancer patients in Taiwan: An exploratory study. Eur J Cancer Care (Engl). 2020 Jul;29(4):e13233. doi: 10.1111/ecc.13233. Epub 2020 Feb 25.
Chen HM, Lee MC, Tian JY, Dai MF, Wu YC, Huang CS, Hsu PK, Duong LT. Relationships Among Physical Activity, Daylight Exposure, and Rest-Activity Circadian Rhythm in Patients With Esophageal and Gastric Cancer: An Exploratory Study. Cancer Nurs. 2024 Mar-Apr 01;47(2):112-120. doi: 10.1097/NCC.0000000000001188. Epub 2023 Jan 14.
Chen HM, Lin YY, Wu YC, Huang CS, Hsu PK, Chien LI, Lin YJ, Huang HL. Effects of Rehabilitation Program on Quality of Life, Sleep, Rest-Activity Rhythms, Anxiety, and Depression of Patients With Esophageal Cancer: A Pilot Randomized Controlled Trial. Cancer Nurs. 2022 Mar-Apr 01;45(2):E582-E593. doi: 10.1097/NCC.0000000000000953.
Chen HM, Tsai CM, Wu YC, Lin KC, Lin CC. Randomised controlled trial on the effectiveness of home-based walking exercise on anxiety, depression and cancer-related symptoms in patients with lung cancer. Br J Cancer. 2015 Feb 3;112(3):438-45. doi: 10.1038/bjc.2014.612. Epub 2014 Dec 9.
Chen HM, Tsai CM, Wu YC, Lin KC, Lin CC. Effect of walking on circadian rhythms and sleep quality of patients with lung cancer: a randomised controlled trial. Br J Cancer. 2016 Nov 22;115(11):1304-1312. doi: 10.1038/bjc.2016.356. Epub 2016 Nov 3.
Chen HM, Wu YC, Tsai CM, Tzeng JI, Lin CC. Relationships of Circadian Rhythms and Physical Activity With Objective Sleep Parameters in Lung Cancer Patients. Cancer Nurs. 2015 May-Jun;38(3):215-23. doi: 10.1097/NCC.0000000000000163.
Related Links
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Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable
Other Identifiers
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2023-04-003B
Identifier Type: -
Identifier Source: org_study_id
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